Fla. pharmacy board wants drug compounders to get permits

Published: Tuesday, December 11, 2012 at 2:39 p.m.

Last Modified: Tuesday, December 11, 2012 at 2:39 p.m.

State regulators on Tuesday began the task of imposing greater oversight over pharmacies that engage in drug compounding, ordering a committee of pharmacists to recommend permitting procedures for pharmacies that make their own medications.

As it stands now, any pharmacist in Florida can create specialized medications for patients who have a doctor's prescription. But recent mistakes by so-called pharmaceutical compounders — pharmacists who produce these kinds of medications in large quantities — have brought intense public scrutiny on the practice, along with calls for greater regulation.

So on Tuesday, the State Board of Pharmacy ordered a committee of its colleagues to come up with a series of state permits that pharmacists would have to be granted before they could create and sell specialized medicines. The three-person committee will come back with recommendations at a later date.

"It helps us as a regulatory body to know exactly what type of practices … are occurring in any kind of pharmacy," said Board of Pharmacy Chairwoman Cynthia Griffin of the proposed new rules.

She and other board members met in Tallahassee to explore other ways to best protect Florida consumers from bad drugs, like the contaminated pain medication that was manufactured by a Boston-area compounding lab and is blamed for an outbreak of fungal meningitis that has sickened nearly 600 people and killed 37 across 19 states.

The proposed permits would allow state health inspectors to keep track of medications being created by pharmacists.

Currently, Florida's pharmacy license and permitting process doesn't give regulators much information about what medicines are being made by the state's 8,000 pharmacists.

In addition to creating a permitting process, the Board of Pharmacy also wants the committee to consider requiring compounders to use a consulting pharmacist to ensure they follow guidelines for making sterile drugs, and it wants to require out-of-state pharmacies doing business in Florida to provide proof of their latest health inspections.

Tuesday's meeting was the second in two months for the Board of Pharmacy, which has acknowledged that compounders operate without enough oversight of the drugs they make and sell. Last month, the board said it wasn't even sure how many pharmacists are engaged in compounding and ordered a survey to try to determine which ones are compounding and what drugs they are making.

The Florida Department of Health reported Tuesday that more than 90 percent of Florida pharmacies completed the mandatory survey. A voluntary survey previously ordered by health officials garnered only a 10 percent response rate from pharmacists.

The recent meningitis outbreak was traced to contaminated lots of methylprednisolone acetate from the New England Compounding Center (NECC) in Massachusetts. Most of the Florida contamination cases were in Marion County involving three local clinics that injected the medicine into patients, mostly to relieve back pain.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make copies of commercially available medications and can only make medications when they are ordered by a doctor. Most make uniquely formulated medicines required by patients who are unable to use medications manufactured by commercial producers. But more recently, pharmacies are mass producing drugs, especially medicines for which there are otherwise shortages.

These medicines, critics say, are created without the same stringent oversight that commercial drug makers endure.

Currently, licensed Florida pharmacists are allowed to compound medications without any additional accreditation. Pharmacists making non-sterile medicines encounter minimal inspections while those making sterile medicines for injection purposes — such as the contaminated medicines behind the outbreak — require a higher level of regulation.

In addition to the meningitis outbreak, compounders have been blamed for other high-profile errors that caused serious health problems. In recent years, two such episodes were traced to Franck's Compounding Lab in Ocala.

In one case, Franck's mixed a bad dose of vitamin supplements that killed two dozen prized polo horses. In another, it was blamed for creating bad batches of eye medications that blinded eye surgery patients in several states.

That last mistake caused owner Paul Franck to sell his business to Wells Pharmacy.

While the Board of Pharmacy works on creating a permitting process for compounders, a key state health official admitted Tuesday that health inspectors may not be up to the task of inspecting compounders to ensure the medicines they are making are safe.

Jeane Clyne, with the Florida Department of Health, told the board that some of her inspectors had little experience inspecting compounding pharmacies. The board recommended she consider hiring consultants to create an inspection process that better takes into account the type of compounding the businesses are performing and creating the necessary records of their findings.

Board members during the meeting also expressed frustration with how to ensure out-of-state pharmacies remain safe and follow good practices. Florida law doesn't allow for Florida inspectors to travel outside the state for inspections nor can they force other states to conduct more frequent inspections or meet Florida compounding standards.

<p>State regulators on Tuesday began the task of imposing greater oversight over pharmacies that engage in drug compounding, ordering a committee of pharmacists to recommend permitting procedures for pharmacies that make their own medications.</p><p>As it stands now, any pharmacist in Florida can create specialized medications for patients who have a doctor's prescription. But recent mistakes by so-called pharmaceutical compounders — pharmacists who produce these kinds of medications in large quantities — have brought intense public scrutiny on the practice, along with calls for greater regulation.</p><p>So on Tuesday, the State Board of Pharmacy ordered a committee of its colleagues to come up with a series of state permits that pharmacists would have to be granted before they could create and sell specialized medicines. The three-person committee will come back with recommendations at a later date.</p><p>"It helps us as a regulatory body to know exactly what type of practices … are occurring in any kind of pharmacy," said Board of Pharmacy Chairwoman Cynthia Griffin of the proposed new rules.</p><p>She and other board members met in Tallahassee to explore other ways to best protect Florida consumers from bad drugs, like the contaminated pain medication that was manufactured by a Boston-area compounding lab and is blamed for an outbreak of fungal meningitis that has sickened nearly 600 people and killed 37 across 19 states.</p><p>The proposed permits would allow state health inspectors to keep track of medications being created by pharmacists.</p><p>Currently, Florida's pharmacy license and permitting process doesn't give regulators much information about what medicines are being made by the state's 8,000 pharmacists.</p><p>In addition to creating a permitting process, the Board of Pharmacy also wants the committee to consider requiring compounders to use a consulting pharmacist to ensure they follow guidelines for making sterile drugs, and it wants to require out-of-state pharmacies doing business in Florida to provide proof of their latest health inspections.</p><p>Tuesday's meeting was the second in two months for the Board of Pharmacy, which has acknowledged that compounders operate without enough oversight of the drugs they make and sell. Last month, the board said it wasn't even sure how many pharmacists are engaged in compounding and ordered a survey to try to determine which ones are compounding and what drugs they are making.</p><p>The Florida Department of Health reported Tuesday that more than 90 percent of Florida pharmacies completed the mandatory survey. A voluntary survey previously ordered by health officials garnered only a 10 percent response rate from pharmacists.</p><p>The recent meningitis outbreak was traced to contaminated lots of methylprednisolone acetate from the New England Compounding Center (NECC) in Massachusetts. Most of the Florida contamination cases were in Marion County involving three local clinics that injected the medicine into patients, mostly to relieve back pain.</p><p>Compounding pharmacies make medications and other medical preparations from scratch. They cannot make copies of commercially available medications and can only make medications when they are ordered by a doctor. Most make uniquely formulated medicines required by patients who are unable to use medications manufactured by commercial producers. But more recently, pharmacies are mass producing drugs, especially medicines for which there are otherwise shortages.</p><p>These medicines, critics say, are created without the same stringent oversight that commercial drug makers endure.</p><p>Currently, licensed Florida pharmacists are allowed to compound medications without any additional accreditation. Pharmacists making non-sterile medicines encounter minimal inspections while those making sterile medicines for injection purposes — such as the contaminated medicines behind the outbreak — require a higher level of regulation.</p><p>In addition to the meningitis outbreak, compounders have been blamed for other high-profile errors that caused serious health problems. In recent years, two such episodes were traced to Franck's Compounding Lab in Ocala.</p><p>In one case, Franck's mixed a bad dose of vitamin supplements that killed two dozen prized polo horses. In another, it was blamed for creating bad batches of eye medications that blinded eye surgery patients in several states.</p><p>That last mistake caused owner Paul Franck to sell his business to Wells Pharmacy.</p><p>While the Board of Pharmacy works on creating a permitting process for compounders, a key state health official admitted Tuesday that health inspectors may not be up to the task of inspecting compounders to ensure the medicines they are making are safe.</p><p>Jeane Clyne, with the Florida Department of Health, told the board that some of her inspectors had little experience inspecting compounding pharmacies. The board recommended she consider hiring consultants to create an inspection process that better takes into account the type of compounding the businesses are performing and creating the necessary records of their findings.</p><p>Board members during the meeting also expressed frustration with how to ensure out-of-state pharmacies remain safe and follow good practices. Florida law doesn't allow for Florida inspectors to travel outside the state for inspections nor can they force other states to conduct more frequent inspections or meet Florida compounding standards.</p><p><i>Contact Fred Hiers at 867-4157 or fred.hiers@starbanner.com.</i></p>